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ozenoxacin

Last Updated: June 11, 2018
Result type: Reports
Project Number: SR0553-000
Product Line: Common Drug Review

Generic Name: ozenoxacin

Brand Name: Ozanex

Manufacturer: Ferrer Internacional, S.A.

Indications: Impetigo

Manufacturer Requested Reimbursement Criteria1: For the topical treatment of impetigo in patients aged 2 months and older.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedDecember 14, 2017
Patient group input closedFebruary 09, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsFebruary 13, 2018
Patient group comments on input summary closedFebruary 21, 2018
Clarification:

- Patient input summary feedback received

Submission receivedJanuary 25, 2018
Submission accepted for reviewFebruary 08, 2018
Review initiatedFebruary 13, 2018
Draft CDR review report(s) sent to applicantApril 30, 2018
Comments from applicant on draft CDR review report(s) receivedMay 09, 2018
Redaction requests from applicant on draft CDR review report(s) receivedMay 16, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJune 08, 2018
Canadian Drug Expert Committee (CDEC) meetingJune 20, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 03, 2018
To
July 05, 2018

Tags

dermatology, pediatrics, impetigo, Ozanex; ozenoxacin; Xepi; impetigo; Pediatric; Paediatric; Child